MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER PLATE,FIXATION,BONE

Catalog Number 04.112.019S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for left clavicle shaft fracture with the plate in question. During the surgery, when the surgeon set the plate, the plate did not fit. The surgeon attempted to bend the plate, but the plate broke in two from the center. The surgeon used another plate and the surgery was completed successfully. There was a surgical delay of about fifteen (15) minutes. The patient was reported as stable. No further information is available. Concomitant device reported: unk- bending inst: plate bender: trauma. This report is for one (1) 3. 5mm ti lcp sup ant clavicle pl w/lat extn 7h/lt/123mm-ster. This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10779064
• MDR Text Key: 214380015
• Report Number: 8030965-2020-08515
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.112.019S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/03/2020 Patient Sequence Number: 1

Treatment

UNK - BENDING INSTRUMENTS: PLATE BENDER: TRAUMA